390164S

GUDID 04546540716040

Kirschner Wire

Stryker Trauma SA

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: 04546540716040
• NIH Device Record Key: 6d913cfe-a836-408f-aa71-f4660f3f25a6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 390164S
• Catalog Number: 390164S
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540716040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162841

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-04
• Device Publish Date: 2017-07-24

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• 07613327614879 - VARIAX: 2024-04-19 Extended Volar DR Plate, standard, L
• 07613327614886 - VARIAX: 2024-04-19 Wrist Add-on, Top Drawer Clip
• 07613327614909 - VARIAX: 2024-04-19 Volar Distal Radius Plate Insert, Left
• 07613327614916 - VARIAX: 2024-04-19 Extended Volar DR Plate, wide, R
• 07613327614930 - VARIAX: 2024-04-19 Extended Volar DR Plate, narrow, L
• 07613327614954 - VARIAX: 2024-04-19 Volar DR Plate, standard, L
• 07613327614961 - VARIAX: 2024-04-19 Volar DR Plate, wide, R